Follow-Up of Bladder Cancer Patients From the New England Study of Environment and Health

Background:

- Bladder cancer is a highly recurrent disease with substantial variability in survival.

- Patients currently undergo repeated cystoscopy for many years after diagnosis.

- There is a need to identify prognostic markers of recurrence and progression to minimize
the need for routine screening and to identify patients who should be treated more
aggressively.

- The New England Study of Environment and Health (NESEH), a population-based case control
study of 1,213 patients in Maine (ME), Vermont (VT), and New Hampshire (NH), provides an
excellent opportunity study the clinical, host-genetic, and environmental determinants
of prognosis.

- Before launching a full-scale follow-up study, we need to determine the feasibility of
following a population-based case series and of obtaining patient-related (vital status,
exposures) and tumor-related (recurrence, progression, pathology) information.

Objectives:

To determine:

- The completeness and quality of information that can be obtained for each patient. The
most important issue is the extent to which medical records from private physicians will
be needed, and whether private physicians are cooperative.

- Our ability to identify next-of-kin (NOK) of deceased patients.

- The proportion of patients (and NOK) that we can contact and enroll.

- The ability of NOK to provide information on exposures.

Eligibility:

-Bladder cancer patients from ME who participated in the original case-control study (ages
30-79, newly diagnosed with histologically-confirmed carcinoma of the bladder, including
carcinoma in situ), excluding those diagnosed after 2003 (5 years of follow-up are needed).

Design:

- Conduct interviews with 40 living patients and the NOK of 9 deceased patients to update
exposure information and find out where the patient received health care, the types of
treatment received, and whether and when the disease recurred or progressed.

- For living patients or NOK that we are unable to locate (an estimated 10 living patients
and 9 NOK), request medical records from health care providers (to see if physicians
will provide records in the absence of an authorization form).

- Evaluate participant and physician response rates and the completeness of the medical
history information obtained.

- We will proceed with the full study if we obtain sufficient medical information for 70%
of the living patients.

- We will examine whether there were important issues related to deceased patients (e.g.,
NOK identification/enrollment, exposure assessment, access to medical records). If so,
consider a simpler approach for this segment of the population (e.g., survival study
based on NDI Plus and information available from the NESEH).

- INCLUSION CRITERIA:

With the exceptions noted below, all bladder cancer patients who participated in the NESEH
and were residents of ME when first diagnosed with bladder cancer will be eligible for this
feasibility study. Patients were eligible for the NESEH if they met the following criteria:

- 30-79 years old at initial diagnosis

- Newly diagnosed with histologically-confirmed carcinoma of the urinary bladder
(including carcinoma in situ) between September 1, 2001 and October 31, 2004

EXCLUSION CRITERIA:

We will exclude from the feasibility study the following NESEH case participants:

- 44 bladder cancer patients (7 percent) first diagnosed at one of seven hospitals
located in remote areas of ME (Aroostook Medical Center, Calais Regional Hospital,
Cary Medical Center, Down East Community Hospital, Houlton Regional Hospital, Northern
Maine Medical Center, and Mount Desert Hospital); this is for cost considerations;

- Patients diagnosed fewer than 5 years before the feasibility study begins (i.e., after
2003)